NCT04627753

Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With PCNSL.

Phase II Study of Lenalidomide/Rituximab Maintenance for Transplantation Ineligible Patients With Primary CNS Diffuse Large B-cell Lymphoma (Nickname: Lemon-C Study)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Kim, Seok Jin · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

* After standard treatment of primary central nervous system lymphoma (PCNSL), high-dose methotrexate induction therapy, and consolidation therapy, most patients reach complete remission, but within the first 6 months, 35-60% of patients refractory to treatment or experience relapse during the first treatment. * The progression-free survival (PFS) period of relapsed patients is 2.2 months (0-29.6 months), and the survival period is reported as 3.5 months (0-29.6 months). After relapse, the majority of patients die within 2-4 months due to neurologic deterioration * Consolidation therapy after induction therapy includes whole-brain radiation therapy, high-dose chemotherapy followed by autologous hematopoietic stem cell transplantation (auto-SCT), and high-dose chemotherapy alone. * However, the median age of the inducing patient is 65 years, and more than half of the patients who are unable to transplant autologous hematopoietic stem cells (auto-SCT) after induction therapy account for more than half. * Therefore, we intend to conduct a study to evaluate the efficacy and safety of maintenance therapy for rituximab and lenalidomide as one of the consolidation therapies for patients with primary central nervous system lymphoma (PCNSL).

Detailed description

-As described, standard treatment for patients with primary central nervous system lymphoma is not yet based on a high level of evidence, and studies on consolidation therapy for elderly patients who cannot transplant this disease are very limited. Based on the Korea National Cancer Incidence Database, about 100 to 150 cases of primary central nervous system lymphoma are diagnosed per year in Korea, and 15 to 30% of them are judged to experience recurrence. Rituximab and lenalidomide (RR) are drugs that are expected to play a role in patients with primary central nervous system lymphoma who have already refractory or relapsed as described above, but there is a big hurdle that the number of patients is limited. Since then, it has not been studied as consolidation therapy in elderly or non-transplantable patients. Therefore, the present investigators attempted to confirm the efficacy and safety of lenalidomide/rituximab maintenance therapy in patients with primary central nervous system lymphoma who received high-dose methotrexate-containing anticancer drug, but could not receive consolidation therapy with autograft.

Conditions

• Primary CNS Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab, lenalidomide	Maintenance for 2 years

Timeline

• Start date: 2020-11-02
• Primary completion: 2025-11-02
• Completion: 2026-11-02
• First posted: 2020-11-13
• Last updated: 2024-08-06

Locations

1 site across 1 country: South Korea